Tafasitamab and Rituximab for the Treatment of Newly Diagnosed Follicular Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

This phase II trial tests how well tafasitamab and rituximab works for the treatment of newly diagnosed follicular lymphoma. Tafasitamab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving tadasitamab and rituximab may work well to treat patients with newly diagnosed follicular lymphoma.

Eligibility criteria

Qualifiers

Age ≥ 18 years old

Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma)

Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm.

Any nodal or extranodal tumor mass with a diameter of ≥ 7 cm.

Disqualifiers

FL grade 3B or transformed FL

Patients receiving any other investigational agents

Patients with known central nervous system involvement of lymphoma

History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the primary investigator (PI) may be included

Trial design

Treatments tested in this trial

  • Rituximab
  • Tafasitamab
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Positron Emission Tomography
  • Survey Administration

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Washington

Lead sponsor

Incyte Corporation

Collaborator